MAUDE Adverse Event Report: COOK INC HIWIRE HYDROPHILIC WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	HWA-35-150
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This mdr is being filed after the associated complaint was reviewed under remediation protocol cap (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The complainant reported that another manufacturer's balloon was loaded onto the hiwire hydrophilic wire guide while working in a fistula.The balloon would not come off of the wire as a result of the wire becoming ¿tacky.¿ the balloon and the wire were removed at the same time, and wire access was lost.It was further noted that a section of the black polymer material was partially sheared.The procedure was successfully completed with another device after gaining access again, and there were no reported serious injuries to the patient as a result of the product problem.

• Brand Name: HIWIRE HYDROPHILIC WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7889467
• Report Number: 1820334-2018-02884
• Device Sequence Number: 16659948
• Product Code: DQX
• UDI-Device Identifier: 00827002362826
• UDI-Public: (01)00827002362826(17)161001(10)10331746
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: HWA-35-150
• Device Lot Number: 10331746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1